FDA.reportPublic FDA data

Cardinal Health Antacid Tablets Drug Facts

Manufacturer
Cardinal Health
Effective date
2021-01-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:55:27

Label at a glance#

ProductLeader Antacid Regular Strength
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Indications and uses

relieves • heartburn • sour stomach • acid indigestion

Dosage and administration

Chew 2 to 4 tablets as symptoms occur or as directed by a doctor.

Storage and handling

• Store below 30°C (86°F) • Keep the container tightly closed • For calcium and magnesium content see Supplement Facts. Safety sealed: Do not use if printed seal under cap is torn or missing

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate USP 500 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

  • do not take more than 15 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Chew 2 to 4 tablets as symptoms occur or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store below 30°C (86°F)
  • Keep the container tightly closed
  • For calcium and magnesium content see Supplement Facts.

Safety sealed: Do not use if printed seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER®

NDC 37205-210-47

Compare to Tums® active ingredient

REGULAR STRENGTH

Antacid Tablets

Antacid/Calcium Supplement

Calcium Carbonate 500 mg

Fast Relief

Relieves: Acid Indigestion, Sour Stomach, Heartburn

Naturally and Artificially Flavored

Peppermint Flavor

150 Chewable Tablets

SATISFACTION GUARANTEED

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Distributed By: Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 1783497

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of TUMS®

Leader Regular Strength Antacid 150 Chewable Tablets
Leader Regular Strength Antacid 150 Chewable Tablets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-210-472025-04-08C16284748780-1f386c64a-2ad4-0266-e053-dadaa90a7c1aCardinal Health Antacid Tablets Drug Facts
37205-210-472023-01-30C16284748780-1f386c64a-2ad4-0266-e053-dadaa90a7c1aCardinal Health Antacid Tablets Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-210-47EA - Each37205-210dbd5aa61-9117-4d52-a853-7765c1e09a8512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-21037205-210-47

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
223493e1-bf6f-44ef-927e-28d748abcc88ef962dab-2c53-48ee-a521-9f3343b5251f2025-04-07WarningsExact identifier
spl set id: ef962dab-2c53-48ee-a521-9f3343b5251f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.